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Neuromodulation and Yoga for Mild Traumatic Brain Injury and Chronic Pain

NCT04517604 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2025-07-16

Study results available
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Summary

The objectives of this VA SPiRE application are to develop a combined neuromodulation and yoga (iTBS+yoga) intervention for Veterans with mild traumatic brain injury (mTBI) and chronic pain, assess the intervention's feasibility and acceptability, and to gather preliminary clinical outcome data on quality of life, function and pain that will guide future studies. This SPiRE project will directly benefit Veterans and VA Services by developing a new, non-pharmacological neurorehabilitation treatment for Veterans with mTBI and chronic pain in need of non-opioid treatment options. Neuromodulation is now offered at 30 VA hospitals and yoga is among the complementary and integrative health programs being rolled out as a part of VAs Whole Health implementation efforts. Thus, should iTBS+yoga ultimately prove to be efficacious, VA facilities will be well-poised to offer this treatment. A novel, activity-based, non-pharmacological treatment for Veterans with mTBI and chronic pain is of great need given the high prevalence of chronic pain.

Conditions

Interventions

DEVICE

Magventure MagProx100 with MagOption

The Magventure C-B60 butterfly coil will be used for single-pulse TMS to determine motor threshold. iTBS will be delivered utilizing the MagVentrure MagPro X100 with MagOption stimulator that includes active and placebo coils (C-B65 Butterfly coils) or active-only Cool-B65 Butterfly (figure 8) coil. Only the active setting will be used.

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Amy A Herrold, PhD BA · Edward Hines Jr. VA Hospital, Hines, IL

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2023-08-31
Completion
2023-08-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04517604 on ClinicalTrials.gov